Scientific advice for veterinary medicines
EMA and the United States’ Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) offer parallel scientific advice procedures to developers of veterinary medicines who intend to apply for authorisation of their products in both regions.
This joint programme enables applicants to exchange views on scientific issues with both authorities simultaneously during the development phase of a new veterinary medicine.
Parallel scientific advice procedures can:
- provide a deeper understanding of regulatory decisions;
- optimise product development;
- avoid unnecessary testing replication or unnecessary diverse testing methodologies.
These procedures are based on the confidentiality arrangement between the European Commission, EMA and FDA-CVM.
From June 2024, the programme includes more defined timelines, an additional meeting between the medicine developer and both authorities, and preliminary written feedback to the medicine developer.
For more information, including on the related timetable, see:
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
